(116 days)
The coaxial introducer set is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.
The proposed coaxial introducer set consists of an inner dilator within a slightly shorter outer sheath. The inner dilator is high density polyethylene and has length of approximately 4.5 inches. The outer sheath is also high density polyethylene and is approximately 3.5 inches long. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub on the inner dilator is high density polyethylene. The hub on the outer sheath is also high density polyethylene. The set may be 4F, 4.5F or 5F.
The kit contains a 21 gauge disposable aspiration and injection needle, a .018 inch diameter guidewire, and a Coaxial Introducer Set consisting of a sheath and dilator.
This document describes the MedAmicus Coaxial Introducer, a device intended to facilitate the introduction of guide wires or catheters into the vascular system. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than proving a novel device's performance through extensive clinical studies and acceptance criteria as might be expected for a new technology with specific performance metrics. Therefore, the questions related to clinical study design, expert ground truth, effect size with AI, etc., are not directly applicable in the context of this 510(k) submission.
Here's an analysis based on the provided text, focusing on the available information regarding performance and equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of acceptance criteria with specific quantitative thresholds that the device must meet, nor does it present detailed performance metrics as one might find in a clinical trial. Instead, it focuses on demonstrating equivalence to predicate devices through material similarity, manufacturing processes, and limited functional testing.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance |
|---|---|
| Material Biocompatibility | Meets all FDA's modified ISO-10993 standard tests (acute systemic toxicity, acute intracutaneous toxicity, cytotoxicity, hemolysis, rabbit pyrogen, sensitization). |
| Bonding Strength | All samples met required specifications, comparable to predicate Boston Scientific device. |
| Sterility Assurance Level (SAL) | Greater than 10^-6 (proven by complete kill of B. var niger spores after half-cycle ETO sterilization). |
| Radiopacity | Sheath and dilator are radiopaque for fluoroscopic visibility. |
| Functional Equivalence | Intended use: introduce up to 0.038-inch guidewire or catheter into vascular system following a 21-gauge needle stick, similar to predicate devices. |
2. Sample Size for the Test Set and Data Provenance
- Bonding Strength Test: "All samples met the required specifications." The exact sample size is not stated, but it implies a sufficient number were tested to draw this conclusion. The data provenance is internal testing by MedAmicus.
- Biocompatibility Testing: Conducted on "MedAmicus' peelable sheath and dilator that uses identical material to that used in the Coaxial Introducer." The specific sample size for each biocompatibility test (e.g., number of animals for toxicity, number of cells for cytotoxicity) is not provided. The data provenance is internal testing, likely by a contract lab specializing in medical device biocompatibility.
- Sterilization Validation: Spore strips (one million spores of Bacillus var niger) were used in sample product. This refers to the biological indicator for sterilization validation, not patient data.
This submission is not a clinical study involving human patients, so there is no "test set" in that sense or data provenance related to patient cohorts.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a 510(k) submission focused on substantial equivalence to existing devices through material and performance comparisons, not a clinical study requiring expert review of patient data for ground truth.
4. Adjudication Method for the Test Set
Not applicable. There is no human-reviewed test set or clinical data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study comparing diagnostic accuracy or clinical outcomes of the device with and without AI assistance, nor does it involve multiple readers interpreting medical cases.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical instrument, not a software algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically used in medical device AI/diagnostic studies is not directly relevant here. Instead, the "truth" is established through:
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (MedAmicus K932323 and Boston Scientific K974640).
- Material Equivalence: Verification that the materials used are identical or highly similar to those in already cleared devices, and pass specified biocompatibility tests.
- Functional Testing: Internal testing demonstrating physical properties (e.g., bonding strength) meet specifications and are comparable to predicate devices.
- Sterilization Validation: Adherence to established standards (AAMI method) for achieving sterility.
8. Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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JUN 2 . 1999
510(k) Summary
MedAmicus Coaxial Introducer
General Information
| Classification | Class II |
|---|---|
| Trade Name | MedAmicus Coaxial Introducer |
| Submitter | MedAmicus, Inc.15301 Highway 55 WestMinneapolis, MN 55447 |
| Contact | Dennis S. MadisonVice President, Quality Assurance/RegulatoryAffairs612-559-2613 |
Predicate Devices
Percutaneous Introducers from MedAmicus, Inc. (K932323) Coaxial Introducers from Boston Scientific, Inc. (K974640)
Device Description Information
Intended Use
The MedAmicus Coaxial Introducer is intended to be used in the exact same manner as the Boston Scientific Coaxial Introducer cleared by the FDA under K974640 and in a similar manner to introducers manufactured by MedAmicus, Inc. and cleared by the FDA under K932323. The intended use of these introducers is to introduce up to a 0.038 inch guide wire or catheter into the vascular system following a small 21 gauge needle stick.
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Device Description
The proposed coaxial introducer set consists of an inner dilator within a slightly shorter outer sheath. The inner dilator is high density polyethylene and has length of approximately 4.5 inches. The outer sheath is also high density polyethylene and is approximately 3.5 inches long. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub on the inner dilator is high density polyethylene. The hub on the outer sheath is also high density polyethylene. The set may be 4F, 4.5F or 5F.
The kit contains a 21 gauge disposable aspiration and injection needle, a .018 inch diameter guidewire, and a Coaxial Introducer Set consisting of a sheath and dilator.
Material Information
The proposed coaxial introducer set consists of a sheath and a dilator. The dilator uses the identical materials as those used in MedAmicus' legally marketed dilators. The sheath material for the proposed device is high density polyethylene identical to that used in the dilator with the exception that it has a durometer of 66 rather than 65 for increased stiffness. The material is produced by the same manufacturer. Materials for the sheath and dilator are processed using equivalent processing technologies as for the predicate device.
Biocompatability testing was conducted on MedAmicus' peelable sheath and dilator that uses identical material to that used in the Coaxial Introducer. Testing included all tests required to be conducted in FDA's modified ISO-10993 standard for the biological evaluation of medical devices. These included: acute systemic toxicity, acute intracutaneous toxicity, cytotoxicity, hemolysis, rabbit pyrogen and sensitization.
Device Performance/Product Testing
Testing of bonding strength between the inner dilator and its hub and the outer sheath and its hub was conducted on sterilized, finished devices to ensure acceptable joint integrity. Boston Scientific's coaxial dilator set was also tested to provide a basis for determining substantial equivalence for the mechanical properties of the proposed device. All samples met the required specifications.
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Sterilization and Packaging Information
The sterilization cycle for the MedAmicus Coaxial Introducer kit is identical to the cycle for the predicate MedAmicus introducers. The ETO sterilization cycle for these products was validated using the AAMI method of three half cycles and one full cycle.
Validation tests were performed with spore strips (one million spores of Bacillus var niger) placed in sample product and sterilized at one half the regular cycle. The results showed a complete kill which proves a Sterility Assurance Level (SAL) of greater than 10-6.
The packaging materials for the MedAmicus Coaxial Introducer Kit are identical to the predicate MedAmicus product. These materials consist of a single sterile barrier using a Tyvek/Mylar pouch.
Substantial Equivalence
The MedAmicus Coaxial Introducer is intended to introduce up to a 0.038 inch guide wire or catheter into the vascular system following a small 21 gauge needle stick. The basic design, methods of manufacturing, and materials used are similar to existing MedAmicus introducer kits and Boston Scientific Coaxial introducers cleared by the FDA. Our application of these devices is substantially equivalent to the aforementioned standard medical procedures already approved for use. The clinical indications for use remain unchanged. MedAmicus believes the MedAmicus Coaxial Introducer is substantially equivalent to currently marketed medical introducer devices employing the same technology.
Conclusion
In conclusion, MedAmicus believes the MedAmicus Coaxial Introducer is substantially equivalent to the predicate MedAmicus and Boston Scientific introducer sets. The intended use, materials, labeling, method of operation and manufacturing methods are substantially equivalent.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
: 必
JUN 28 1999
Mr. Dennis S. Madison Medamicus Corporation 15301 Highway 55 West 55447 Minneapolis, MN
K990705 Re: Coaxial Introducer Regulatory Class: II (two) Product Code: 74 DYB Dated: May 5, 1999 Received: June 3, 1999
Dear Mr. Madison:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Dennis S. Madison
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
S10(k) Number (if known): K 990 705
I NTRODUCER Device Name:
Indications for Use
The coaxial introducer set is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chito
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number __
(Optional Format 3-10-98)
For Prescription USE ONLY
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).